The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Primado Surgical Drill.
| Device ID | K080722 |
| 510k Number | K080722 |
| Device Name: | PRIMADO SURGICAL DRILL |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | NAKANISHI, INC. 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt NAKANISHI, INC. 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-13 |
| Decision Date | 2008-09-17 |